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Abstract:

A combined tube set for a disposable water bottle for a medical
instrument includes a cap with threads suitable for attachment to various
water bottles. The combined tube set provides a first tube set for
rinsing that includes an air and water tubes, and air/water connector The
combined tube set also provides a second tube set for irrigation that
includes an irrigation connector, backflow valve(s), and flexible tubing
section. In some embodiments, the tube set can provide warm and/or humid
gas to the endoscope.

Claims:

1. A combined tube set comprising: a first tube set utilized to provide
rinsing fluid for an endoscope, wherein the first tube set provides an
air tube and a water tube; and a second tube set utilized to provide
irrigation fluid for the endoscope, wherein the second tube set
optionally comprises a flexible section.

2. A tube set of claim 1 further comprising: a bottle cap connected to
the first tube set and the second tube set, wherein the bottle cap
provides threads that allow the bottle cap to be attached to a variety of
different water bottles; and a liner in the bottle cap, wherein the liner
forms an air-tight seal between the bottle cap and a water bottle.

3. A combined tube set comprising: a first tube set utilized to provide
rinsing fluid for an endoscope, wherein the first tube set provides an
air tube and a water tube; a second tube set utilized to provide
irrigation fluid for the endoscope, wherein the second tube set
optionally comprises a flexible section; and a third tube utilized to
provide gas to the system.

4. A tube set of claim 3 further comprising: a bottle cap connected to
the first tube set, the second tube set, and the third tube set, wherein
the bottle cap provides threads that allow the bottle cap to be attached
to a variety of different water bottles; and a liner in the bottle cap,
wherein the liner forms an air-tight seal between the bottle cap and a
water bottle.

5. A tube set of claim 1 further comprising an adapter or a connector
attached to the end of the second tube set, wherein the adapter or
connector is utilized to directly attach the second tube set to the
endoscope.

6. A tube set of claim 3 further comprising an adapter or a connector
attached to the end of the second tube set, wherein the adapter or
connector is utilized to directly attach the second tube set to the
endoscope.

7. An adapter that passes water and gas between a tube set with separate
gas, irrigation water, and rinsing water tubes and an endoscope, the
adapter having a universal input connector for attaching a variety of
tubes, other adapters and/or endoscopes thereto.

8. A tube set of claim 1 with a connector at the end of the first tube
set which universally connects to any of several adapters as in claim 7.

9. A tube set of claim 3 with a connector at the end of the first tube
set which universally connects to any of several adapters as in claim 7.

10. An adapter that passes water and gas between a tube set with separate
gas and rinsing water tubes and an endoscope, the adapter having a
universal input connector for attaching a variety of tubes, other
adapters and/or endoscopes thereto.

11. A tube set of claim 2 where the geometry of the liner causes the
liner to form an air tight seal on any of several bottles by using a
varying inner diameter to compress the liner against the bottles'
different outer diameters and/or different rim heights.

12. A tube set utilized to provide rinsing fluid to an endoscope, wherein
the tube set provides an air tube and a water tube, with a filter in the
air path.

13. A tube set of claim 12 where (i) the filter is incorporated in the
connector that attaches the tube set to the endoscope or (ii) the filter
is incorporated in the bottle cap.

14. A tube set utilized to provide rinsing fluid for an endoscope,
wherein the tube set provides an air tube and a water tube, with a
backflow check valve in the water path.

15. A tube set of claim 14 where the backflow check valve is incorporated
in the connector that attaches the tube set to the endoscope.

16. A tube set of claim 14 where the backflow check valve is incorporated
in the bottle cap.

17. A tube assembly comprising: a first tube set configured to provide a
liquid to an instrument, wherein the first tube set provides a gas and
the liquid to the instrument; and a second tube set configured to provide
the liquid to the instrument, wherein the second tube set optionally
comprises a flexible section.

18. A tube assembly according to claim 17, wherein (i) the tube assembly
further comprises a third tube set configured to provide gas to the
instrument or (ii) the liquid is the same composition in the first tube
set and the second tube set.

19. A tube assembly according to claim 18, wherein the instrument
comprises an endoscope, the gas of the first tube set comprises air, the
liquid of the first tube set and the second tube set comprises water and
the second tube set comprises a pinch clip connected thereto and when the
pinch clip is in a closed position it prevents the water flow in the
second tube set.

20. A tube assembly according to claim 18, wherein the gas of the third
tube set comprises carbon dioxide.

21. A tube assembly according to claim 17, further comprising a bottle
cap connected to the first and second tube set, wherein the bottle cap is
configured to connect to a bottle.

22. A tube assembly according to claim 21, wherein the bottle cap further
comprises a liner disposed in the bottle cap, wherein the liner forms an
air-tight seal between the bottle cap and the bottle and the bottle cap
has threading configured to connect the cap to the bottle.

23. A tube assembly according to claim 17, wherein at least one of (i)
the first tube set comprises an air tube and a water tube, wherein at
least a portion of the water tube runs within the air tube and the water
tube extends within the bottle; or (ii) the first tube set comprises an
air tube and a water tube, the air tube separate from the water tube and
the water tube extends within the bottle.

24. A tube assembly according to claim 18, wherein at least one of (i)
the first tube set comprises an air tube and a water tube, wherein at
least a portion of the water tube runs within the air tube and the water
tube extends within the bottle; (ii) the first tube set comprises an air
tube and a water tube, the air tube separate from the water tube and the
water tube extends within the bottle; or (iii) the first tube set, the
second tube set, and the third tube set are separate from each other.

25. A tube assembly according to claim 18, wherein at least one of (i)
the first, second, and/or third tube set comprise at least one air
filter, pincher clip, back flow valve and/or connector; or (ii) a portion
of the first, second, and/or third tube is contained within an adapter.

26. A tube assembly according to claim 22, wherein at least one of (i)
the cap is removable from at least one tube set, (ii) the tube assembly
comprises an adapter and/or a connector, at least one of which is
permanently connected to at least one tube set; (iii) the tube assembly
comprises an adapter and/or a connector, at least one of which is
removably connected to at least one tube set; or (iv) the cap and/or at
least one tube set is vented.

27. A tube assembly according to claim 18, wherein at least one of (i)
the gas provided to the first or third tube set comprises a heated and/or
humidified gas; (ii) the gas provided to the third tube set comprises
heated and/or humidified carbon dioxide obtained by passing the heated
gas through a liquid in a bottle; (iii) the gas provided to the third
tube set is carbon dioxide; or (iv) the third tube set comprises an end
configured for placement within a bottle, the end having a tip configured
to reduce a size of carbon dioxide gas bubbles provided to the bottle
from a carbon dioxide source to increase a rate of carbon dioxide
humidification or the end having a tip without such configuration.

28. A method of making the combined tube set of claim 1, wherein the
combined tube set comprises an air/water connector or adapter, which said
connector or adapter is overmolded and connected to the tube set.

29. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 1
and connecting the combined tube set to the endoscope and performing the
endoscopic procedure.

30. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 2
and connecting the combined tube set to the endoscope and performing the
endoscopic procedure.

31. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 3
and connecting the combined tube set to the endoscope and performing the
endoscopic procedure.

32. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 4
and connecting the combined tube set to the endoscope and performing the
endoscopic procedure.

33. A tube set of claim 4 where the geometry of the liner causes the
liner to form an air tight seal on any of several bottles by using a
varying inner diameter to compress the liner against the bottles'
different outer diameters and/or different rim heights.

34. An adapter according to claim 10 that passes water and gas between a
tube set with separate gas and rinsing water tubes and an endoscope, the
adapter having a universal input connector for attaching a variety of
tubes, other adapters and/or endoscopes thereto, wherein (i) the
universal connector is at an end of a first tube set, which universally
connects to any of several adapters or (ii) the universal connector is at
an end of a first tube set, which universally connects to any of several
adapters and the tube set further comprises a second and third tube.

35. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 1
and connecting the combined tube set to the endoscope, providing heated
and/or humidified air to the endoscope and performing the endoscopic
procedure.

36. A method of making the combined tube set of claim 3, wherein the
combined tube set comprises an air/water connector or adapter, which said
connector or adapter is overmolded and connected to the tube set.

37. A method of performing an endoscopic procedure, the method comprising
connecting a bottle containing fluid to the combined tube set of claim 3
and connecting the combined tube set to the endoscope, providing heated
and/or humidified air to the endoscope and performing the endoscopic
procedure.

[0002] This application relates to medical instrument systems. More
particularly, a combined tube set for insufflation, irrigation and
rinsing that allows an endoscopic system to be connected to a water
bottle.

BACKGROUND

[0003] Endoscopic instruments have been developed to provide surgeons with
an internal view of the organ or body passage requiring treatment. Such
endoscopes typically have channels through which flexible instruments,
such as a miniaturized forceps, are inserted and advanced. The endoscope
assembly includes an elongated flexible cable equipped at one end with an
eyepiece or other viewing means and at the other end with an imaging
means. The cable transmits images or image-producing signals from the
illuminated operative site to the viewing means so that the surgeon will
have visual confirmation of the action of the instrument's working end.
The cable also provides a flow passage for the delivery of fluid (liquid
or gas) for irrigation, insufflation, rinsing, or other purposes. It may
be necessary to provide the optic head with a flow of sterile water. The
passage of the sterile water across the optic head prevents the buildup
of materials on the imaging means. This flow of water operates, in a
sense, like a windshield wiper/washer assembly.

[0004] In normal practice, the endoscopic instrument has a control body,
which provides several ports that allow connectors to be attached for
irrigation, insufflation, rinsing, or other purposes. These ports may
include a variety of fittings that are suitable for various purposes. For
example, air and water ports can receive an air/water connector suitable
for providing air and/or water for rinsing and other purposes. As such,
the air and water are delivered through the connector into the light
guide connector of the endoscope. The light guide connector or the
control body can also include an irrigation port so as to allow
irrigation water to be directly provided to the endoscope. Suitable
valves are provided on the control body so as to control the flow of
water and/or air through the control body and the flexible cable of the
endoscope.

[0005] Unfortunately, there is usually a great expense associated with
maintaining sterility of the equipment and/or water. Sterile water can be
provided for rinsing from a water bottle that is connected to the
endoscopic instrument via tubing. The tubing has a fitting at one end so
as to allow the tube to be connected to the air/water port of the
endoscopic instrument, and the other end of the tubing is inserted into
the water bottle. Typically, the fitting will include two tubes, one
providing water and the other providing air. Sometimes the two tubes may
be concentric with an inner tube providing water and an outer tube
providing air. The inner tube extends through a cap into the water
bottle, and the outer tube is connected to the cap of the water bottle.
Air may be delivered through the area between the inner tube and the
outer tube so as to pressurize the interior of the water container. In
some embodiments, the gas that pressurizes the bottle and insufflates the
lumen may be supplied through a separate tube that interfaces with the
bottle cap; in such a system, the gas flows from the bottle to the
endoscope through the space between the inner tube and the outer tube.
The gas flowing into the bottle increases the pressure within the bottle.
When a valve in the endoscope is opened, the pressure in the bottle will
force water to flow through the inner tube and into the endoscope at a
desired rate. For example, inner and outer tube sets that are utilized
with endoscopes are described in U.S. Pat. Nos. 6,210,322 and 6,485,412.
These entire disclosures are herein incorporated by reference into the
present application.

[0006] The purpose of irrigation is to clear debris from the field of
view. When debris such as digestive waste, mucous, blood, and detached
tissue cover portions of the lumen wall, the operator may be unable to
make a proper assessment of the condition of the tissue or perform
actions such as biopsy removal or cautery. When irrigation is desired,
the endoscopic instrument can be connected to another water bottle using
another set of tubing. One end of an irrigation tube is connected to an
irrigation port of the endoscopic instrument, and the other end of the
tubing extends through a cap so that it may be placed in a water bottle.
The irrigation tube may provide a section of flexible tubing that is
insertable into a peristaltic pump. The peristaltic pump provides water
flow to the endoscope that is suitable for irrigation. The irrigation
system moves water by drawing it out of the bottle with a peristaltic
pump, so it requires a vent to allow air to enter the bottle. In
contrast, the insufflation and lens rinsing system moves water by pushing
it out of the bottle with internal pressure, so the tubing and bottle
assembly must be sealed to maintain the pressure.

[0007] After usage, the two water bottles, the tubing, and the associated
fittings are sterilized or disinfected if they are not disposable items.
In the case that the items are disposable, two water bottles, tubing, and
associated fittings are discarded. If the items are sterilized or
disinfected, there is a considerable labor expense associated with
cleaning, and disinfecting or autoclaving. Additionally, there is also
the possibility of residual contaminants residing in the area of
connection between the tubes and the bottle. This creates a considerable
expense to the hospital in either case. In some systems, two bottles are
required when the user desires to perform both functions (irrigation and
rinsing) because the designs of these systems treat them as separate and
independent, individual systems.

[0008] Research has demonstrated that there is a clinical benefit when
insufflation is performed using warm (e.g. body temperature) water
instead of dry room temperature air. It is expected that this benefit is
due to the fact that the warm water is more similar to the natural
surroundings of the internal tissue than the cool, dry air. The sudden
loss of temperature caused by insertion of air can make the muscles in
the lining of the lumen contract and affect blood flow to the tissue.
Also, when warm water is used for insufflation, the debris remaining on
the tissue is readily washed away, which improves visibility for cancer
screening when the user removes the water and adds air for insufflation.
Warm water infusion typically is performed as the endoscope is inserted
into the patient. The water is subsequently removed and replaced with air
as the endoscope is being removed and the operator is looking for
problematic tissues (such as cancerous tumors).

[0009] Just as the tissue is most commonly subjected to warm liquids and
not cool dry air, the gas that does pass through the digestive tract
tends to be warm and humid. Thus it is advantageous to use warm, humid
gas whenever insufflation is performed with gas. In some endoscopic
systems, the gas that enters the endoscope for insufflation first passes
through the water bottle and then into the endoscope. In such a system,
it is possible to warm the gas prior to it entering the bottle and/or
warm the water in the bottle. If the gas is then forced to enter the
bottle at the bottom and bubble to the top, it absorbs water and heat
then leaves the bottle warm and humid as it travels to the endoscope for
insufflation. The luminal wall may cramp if the tissue is dried or cooled
by the gas used for insufflation. If the gas used for this procedure is
carbon dioxide instead of atmospheric air, the carbon dioxide absorbs
into the tissues more than 100 times faster.

[0010] The absorption rate of carbon dioxide into digestive tissues is 100
to 150 times that of oxygen and nitrogen, which combine to make up about
99% of atmospheric air. Because carbon dioxide is absorbed into the
tissues and expired through the respiratory system, the gas in the lumen
does not have to pass through the remainder of the digestive system, thus
improving patient comfort and speeding recovery.

[0011] The lens rinsing system, similar to the irrigation system,
comprises a continuous liquid path interrupted only by valves. (The
irrigation system fluid path also is interrupted by the pump rollers.) It
is desirable to maintain sterility of the water in the water bottle that
serves as a source of water for lens rinsing. Thus, it is desirable to
add a check valve in the lens rinsing flow path. This check valve is, in
some embodiments, incorporated in the air/water connector of the tube set
since the valve can then be disposed of with the tube set rather than
being reprocessed with the endoscope. The check valve can help to prevent
cross-contamination.

[0012] Thus, there is a need to develop new devices and methods to reduce
or eliminate the risk of contaminating the tube set used in endoscopic
procedures and reduce or eliminate the risk of infecting the patient.

SUMMARY

[0013] New devices and methods are provided that reduce or eliminate the
risk of contaminating the endoscopic tube set and reduce or eliminate the
risk of infecting the patient. In some embodiments, a water bottle
adapter is provided for use with an endoscopic instrument. The water
bottle adapter includes a cap suitable for attachment to the neck of a
water bottle with a first set of tubing for rinsing and a second set of
tubing for irrigation. The first set of tubing includes air and water
tubes. One end of the first set of tubing provides a first connector that
can be attached to a port on an endoscopic instrument. This first
connector may have one or more check valves to prevent water, air, and
other medical gasses from moving in an undesirable direction. The end of
the air tube opposite the connector is connected to the water bottle cap,
and the end of the water tube opposite the connector is connected to the
water bottle cap and extends through the water bottle cap. The second set
of tubing for irrigation may provide for a flexible section of tubing
that is insertable into a peristaltic pump. One end of the irrigation
tubing provides a second connector that can be attached to an irrigation
port of the endoscopic instrument, and the other end extends through the
water bottle cap.

[0014] In some embodiments, there is a combined tube set comprising: a
first tube set utilized to provide rinsing fluid for an endoscope,
wherein the first tube set provides an air tube and a water tube; and a
second tube set utilized to provide irrigation fluid for the endoscope,
wherein the second tube set provides a flexible section.

[0015] In some embodiments, there is a combined tube set comprising: a
first tube set utilized to provide rinsing fluid for an endoscope,
wherein the first tube set provides an air tube and a water tube; a
second tube set utilized to provide irrigation fluid for the endoscope,
wherein the second tube set provides a flexible section; and a third tube
utilized to provide gas to the system.

[0016] In some embodiments, there is an adapter that passes water and gas
between a tube set with separate gas, irrigation water, and rinsing water
tubes and an endoscope.

[0017] In some embodiments, there is an adapter that passes water and gas
between a tube set with separate gas and rinsing water tubes and an
endoscope.

[0018] In some embodiments, there is a tube set utilized to provide
rinsing fluid to an endoscope, wherein the tube set provides an air tube
and a water tube, with a filter in the air path.

[0019] In some embodiments, there is a tube set utilized to provide
rinsing fluid for an endoscope, wherein the tube set provides an air tube
and a water tube, with a backflow check valve in the water path.

[0020] In some embodiments, there is a tube assembly comprising: a first
tube set configured to provide a liquid to an instrument, wherein the
first tube set provides a gas and the liquid to the instrument; and a
second tube set configured to provide the liquid to the instrument,
wherein the second tube set may comprise a flexible section.

[0021] Additional features and advantages of various embodiments will be
set forth in part in the description that follows, and in part will be
apparent from the description, or may be learned by practice of various
embodiments. The objectives and other advantages of various embodiments
will be realized and attained by means of the elements and combinations
particularly pointed out in the description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In part, other aspects, features, benefits and advantages of the
embodiments will be apparent with regard to the following description,
appended claims and accompanying drawings where:

[0023] FIG. 1 illustrates an embodiment of an air/water tube set;

[0024]FIG. 2 illustrates an embodiment of an air/water tube set secured
to a water bottle;

[0034] FIG. 7 illustrates an embodiment of air filter incorporated into a
bottle cap;

[0035] FIG. 8 illustrates an embodiment of an air/water connector with a
check valve;

[0036]FIG. 9A illustrates an embodiment of an inline air filter assembly;

[0037]FIG. 9B illustrates an embodiment of an inline air filter assembly
with an offset water tube passage;

[0038] FIG. 9C illustrates an orthogonal view of an embodiment of an
inline air filter assembly with an offset water tube passage;

[0039] FIG. 10 illustrates an embodiment of an air and water connector
with a check valve and an inline air filter;

[0040] FIG. 11A illustrates an embodiment of a liner;

[0041] FIG. 11B illustrates a cross sectional view of an embodiment of a
liner having a substantially L-shaped cross section;

[0042]FIG. 12 illustrates a back view of an embodiment of an air and
water connector with a back flow valve; and

[0043]FIG. 13 illustrates a front view of an embodiment of an air and
water connector with a back flow valve.

[0044] It is to be understood that the figures are not drawn to scale.
Further, the relation between objects in a figure may not be to scale,
and may in fact have a reverse relationship as to size. The figures are
intended to bring understanding and clarity to the structure of each
object shown, and thus, some features may be exaggerated in order to
illustrate a specific feature of a structure.

DETAILED DESCRIPTION

[0045] For the purposes of this specification and appended claims, unless
otherwise indicated, all numbers expressing quantities of ingredients,
percentages or proportions of materials, reaction conditions, and other
numerical values used in the specification and claims, are to be
understood as being modified in all instances by the term "about."
Accordingly, unless indicated to the contrary, the numerical parameters
set forth in the following specification and attached claims are
approximations that may vary depending upon the desired properties sought
to be obtained by the present invention. At the very least, and not as an
attempt to limit the application of the doctrine of equivalents to the
scope of the claims, each numerical parameter should at least be
construed in light of the number of reported significant digits and by
applying ordinary rounding techniques.

[0046] Notwithstanding the numerical ranges and parameters set forth
herein, the broad scope of the invention are approximations, the
numerical values set forth in the specific examples are reported as
precisely as possible. Any numerical value, however, inherently contains
certain errors necessarily resulting from the standard deviation found in
their respective testing measurements. Moreover, all ranges disclosed
herein are to be understood to encompass any and all subranges subsumed
therein. For example, a range of "1 to 10" includes any and all subranges
between (and including) the minimum value of 1 and the maximum value of
10, that is, any and all subranges having a minimum value of equal to or
greater than 1 and a maximum value of equal to or less than 10, e.g., 5.5
to 10.

[0047] Reference will now be made in detail to certain embodiments of the
invention, examples of which are illustrated in the accompanying
drawings. While the invention will be described in conjunction with the
illustrated embodiments, it will be understood that they are not intended
to limit the invention to those embodiments. On the contrary, the
invention is intended to cover all alternatives, modifications, and
equivalents that may be included within the invention as defined by the
appended claims.

[0048] It is noted that, as used in this specification and the appended
claims, the singular forms "a," "an," and "the," include plural referents
unless expressly and unequivocally limited to one referent. Thus, for
example, reference to "a tube set" includes one, two, three or more
tubes.

[0049] We refer now to the drawings wherein depicted elements are not
necessarily shown to scale and wherein like or similar elements are
designated by the same reference numeral through the several views.

[0050] FIG. 1 shows an example of a system for connecting a water bottle
to an endoscope for gas insufflation and lens rinsing or an air/water
tube set 10. Tube set 10 includes water tube 12 and air tube 14. While
water tube 12 extends through air tube 14 in the example shown, it should
be noted that in other embodiments the water and air tubes may be
separated or the water tube may not extend through the air tube. Tube set
10 provides a connector 18 on one end of the tube set that can be
connected to an endoscope (not shown). Cap 16 is connected to the air
tube 14 and water tube 12 extends through cap 16. In some embodiments,
the current system is configured to be used with a single bottle.
However, it will be understood that, in some embodiments, more than one
bottle can be used.

[0051]FIG. 2 shows an example of an air/water tube set 10 attached to
water bottle 60. When cap 16 is placed on a water bottle, water tube
extends into the water bottle to provide a source of water for the
endoscope. Connector 18 (shown as an Olympus connector in contrast to
FIG. 1) may be connected to ports on the endoscope to provide water for
lens rinsing.

[0052]FIG. 3 shows an example of a system for connecting a water bottle
to an endoscope for irrigation or an irrigation tube set 20. One end of
the irrigation tube set 20 has a connector 22 that can be mated to an
endoscope. Irrigation tube set 20 may include flexible section 24 of
tubing that can be inserted into a peristaltic pump, which pumps the
water to the endoscope for irrigation. Irrigation tube set 20 is attached
to cap 26 and the water bottle end 28 of the irrigation tube set 20
passes through the cap so that it may extend into a water bottle when the
cap is placed on the water bottle. While the irrigation tube set 20 is
formed from three separate pieces of joined tubing as described, in other
embodiments, irrigation tube 20 may be formed from fewer or more joined
tubes. Cap 26 provides vent 30. Since the pump is drawing water through
the tubing, an equivalent volume of air may be allowed to enter the
bottle. In the embodiment shown, the air is filtered, whereas in some
embodiments the air is not filtered, so it may enter by some other gap in
the system.

[0053]FIG. 4 shows an example of endoscope light guide connector 72 with
several ports, such as air/water ports 32 and irrigation port (not
shown). Connector 18 for air/water tube set 10 connects to air/water
ports 32 of endoscope 72. Connector 22 for irrigation tube set 20 (of
FIG. 3) connects to irrigation port (not shown) of endoscope 72. When
connectors 18 and 22 (of FIG. 3) are connected to endoscope 72 water for
lens rinsing or irrigation can be provided to the endoscope and the gas
insufflation system can be pressurized.

[0054] Air/water tube set 10 and irrigation tube set 20 require two
separate water bottles for use with endoscope 72. If the tube sets and
water bottles are reusable, great expense is associated with maintaining
sterility of the equipment and/or water. There is a considerable labor
expense associated with manual or automated cleaning, and disinfection or
autoclaving the equipment. Additionally, there is also the possibility of
residual contaminants remaining in the area of connection between the
tubes and the bottle. Further, because air/water tube set 10 and
irrigation tube set 20 each require their own water bottle more equipment
must be sterilized, or disposed of if not reusable, after the equipment
has been used.

[0055] Additionally various types of water bottles and water containers
exist for endoscope systems. Presently, disposable water bottles are
manufactured in 250 milliliter, 500 milliliter and 1,000 milliliter
sizes. These water bottles have slightly varying diameter necks of
slightly varying lengths. The thread structure on the neck of each of
these water bottles is slightly different. The difference in the length
of neck and configuration of threads is the result of water bottles being
manufactured by several different companies utilizing their respective
designs. As such, a need has developed so as to allow for the adaptation
of the various water containers to the various endoscope systems, which
are offered. Any standardization that can be achieved will eliminate the
need to maintain an inventory of products for each of the various types
of water bottles available. Although an endoscope is shown in FIG. 4, it
will be understood that other medical instruments can be used with the
present tube assembly and/or cap. These instruments include, for example,
colonoscopes, laparoscopes, bronchoscopes, or any medical instruments
with a camera that requires use of fluid (e.g., water, saline solution,
dextrose solution, Ringers solution, Lactated Ringer's solution, or
combinations thereof or the like) for use.

[0056] FIG. 5A shows an illustrative embodiment of a combined tube set
100. Combined tube set 100 includes air/water tube set 104, irrigation
tube set 106, bottle cap 130, air/water connector 140, and irrigation
connector 150. Irrigation connector 150 can be a universally adaptable
connector, such as a luer connector. Irrigation connector 150 can
alternately be a connector designed for direct connection to the
endoscope. The air/water tube set 104 is shown as a water tube 120
extending through air tube 110 from bottle cap 130 to air/water connector
140. While air/water connector 140 is shown as a connector suitable for
connection to an Olympus® endoscope, it should be recognized that any
suitable connector may be utilized to facilitate the various types and/or
brands of endoscopes used during the endoscopic procedure.

[0057] Air/water connector 140 and/or irrigation connector 150 can
alternately be a universally adaptable connector design. Further, in
other embodiments, the tubing arrangement of the tube sets may also be
modified to accommodate various types and/or brands of endoscopes. For
example, the air/water connector 140 and the irrigation connector 150 may
utilize any variety of connector that is suitable for connecting combined
tube set 100 to any type or brand of endoscope or a fitting may be mated
with an adapter body that allows a tube set to be utilized with a
particular brand and type of endoscope (e.g. U.S. Pat. Nos. 6,210,322 and
6,485,412). In some embodiments, a universal connector or adapter
connected to the endoscope may receive both air/water connector 140 and
the irrigation connector 150. For example, combined tube set 100 may be
suitable for connection with a Fujinon® AJ-510 or Byrne Medical
100141 adapter. Further, in some embodiments, the universal connector may
be moved away from the endoscope as shown in FIG. 5C. While water tube
120 extends through air tube 110 in the embodiment shown, in some
embodiments, the air tube and water tube may be separated i.e. the water
tube is not contained within the air tube. In a separated air and water
tube arrangement, air/water connector 140 may provide a fitting that may
be mated with an adapter body that provides a connector that is suitable
for connection with an endoscope utilizing a concentric air and water
tube arrangement.

[0058] In the air/water tube set 104, water tube 120 extends from
air/water connector 140 through the bottle cap 130. Air tube 110 has a
larger diameter than water tube 120 and extends from air/water connector
140 to bottle cap 130. Air tube 110 and water tube 120 may be made from a
plastic material, elastomeric material, or any suitable material or
combination of materials. Air tube 110 and water tube 120 may be secured
to air/water connector 140 by ultraviolet gluing, any suitable adhesive,
or any suitable attachment means. While water tube 120 passes through
bottle cap 130, air tube 110 may be secured to bottle cap 130 by
ultraviolet gluing, any suitable adhesive, or any suitable attachment
means. Because air tube 110 has a larger diameter than water tube 120, an
annular air passage is created between the outer surface of water tube
120 and the inner surface of air tube 110. The annular air passage
extends from bottle cap 130 to air/water connector 140.

[0059] Bottle cap 130 can be secured to the neck of a water bottle (not
shown), thereby allowing an end of water tube 120 to extend into the
water bottle. Bottle cap 130 can be made of a plastic material,
elastomeric material, and/or any suitable material or combination of
materials. Water tube 120 may have an anchor 160 attached to one end to
weigh down water tube 120 into the liquid contained in the water bottle.
Weight 160 serves to assures that end of water tube 120 will reside
adjacent to the bottom of the sterile water bottle. Weight 160 provides
an opening (not shown) that allows fluid to pass through water tube 120
to air/water connector 140. In some embodiments, weight 160 may be
omitted. Weight 160 can be ultravioletly glued to end of water tube 120
or secured by any suitable adhesive or any suitable attachment means.

[0060] Bottle cap 130 has inner threads which are particularly adapted for
joining with the threads of a variety of different water bottles, as
discussed in more detail below. Bottle cap 130 may include one or more
gaskets (not shown) to facilitate a substantially air tight seal between
bottle cap 130 and a water bottle. When bottle cap 130 is secured to a
water bottle and air/water connector 140 is connected to an endoscope,
air may pass from the endoscope to the water bottle via the annular air
passage created between the outer surface of water tube 120 and the inner
surface of air tube 110. Note that in other embodiments the tubes may be
separate. Because bottle cap 130 creates an air tight or nearly air tight
seal, forcing air into the water bottle creates pressure in the bottle
that forces water through a first end of water tube 120 having weight or
anchor 160 towards a second end of water tube 120 having air/water
connector 140. Although a weight or anchor 160 is shown, this is an
optional component and the tube set does not require a weight or anchor.

[0061] Irrigation tube set 106 is also connected to bottle cap 130 to
provide combined tube set 100. Irrigation tube set 106 includes
irrigation connector 150, back flow valve(s) 180, and flexible tubing
section 190. A first end of irrigation tube set 106 provides irrigation
connector 150, which may be connected to an endoscope. In contrast to
air/water tube set 104, irrigation tube set 106 provides a single tube.
Irrigation tube set 106 may be made from a plastic material, elastomeric
material, or any suitable material or combination of materials.

[0062] Irrigation tube set 106 may include one or more backflow valves 180
to prevent backflow of water into the water bottle. Irrigation tube set
106 may include flexible tubing section 190, which is insertable into a
peristaltic pump. In the embodiment shown, backflow valves 180 is placed
at the end of tube set 106 that connects to the endoscope. However, in
other embodiments, one or more backflow valves 180 may be placed
elsewhere on irrigation tube set 106, such as near tube end 200 which is
placed in the water. Backflow valves 180 prevent or limit backflow of
water back into the water bottle, thereby reducing the risk of potential
contamination of the sterile water. In some embodiments, backflow valves
may also be utilized in the air/water tube set 104. The backflow valve
can be different designs, for example, a flap valve, duck-bill valve or
the like.

[0063] Tubes of the irrigation tube set 106 may be secured to bottle cap
130, irrigation connector 150, and/or backflow valve(s) 180 by
ultraviolet gluing, any suitable adhesive, or any suitable attachment
means. When bottle cap 130 is placed on a water bottle, water source end
200 of irrigation tube set 106 extends into the water bottle. As with
water tube 120 of air/water tube set 104, water source end 200 of
irrigation tube set 106 may include an anchor or weight (not shown) to
weigh down water source end 200 towards the bottom of the sterile water
bottle.

[0064] Separated tube sets shown in FIGS. 1 and 3 include two separate
water bottles that may not be fully utilized during the use of an
endoscope. When the use of the endoscope is complete, the two water
bottles may be discarded to prevent future contamination of the water
and/or equipment. Further, if the tube sets are disposable, two tube sets
are discarded. If the tube sets are reusable, the equipment must be
manually or automatically cleaned and disinfected or autoclaved to
sterilize the equipment for future use. In contrast, combined tube set
100 allows a water source for irrigation and rinsing to be provided by a
single water bottle used during the endoscopic procedure, thereby
minimizing waste. Further, combined tube set may be made of a low cost,
disposable material so that labor and cost associated with cleaning and
autoclaving is avoided.

[0065]FIG. 5B is an illustrative embodiment of a tube assembly (e.g.,
combined irrigation, air/water, and gas tube set) 210. Combined
irrigation, air/water, and gas tube set 210 may provide an air/water tube
set 104, irrigation tube set 106, and bottle cap 130 similar to the tube
set shown in FIG. 5A. Additionally, combined irrigation, air/water, and
gas tube set 210 also provides gas tube set 215. Gas (e.g. air, carbon
dioxide, nitrogen, oxygen, or combination thereof or other medical gas)
may be supplied to the bottle by gas tube set 215 attached to bottle cap
130. Gas supply connector 225 may be connected to a gas source and gas
valve 220 may be utilized to open and close the flow of gas into a water
bottle. Gas valve 220 is optional and may not be utilized in other
embodiments. Gas supply connector 225 may incorporate a backflow valve,
which allows gas to flow in only one direction. In some embodiments, the
backflow valve may be located at end 230 of gas tube set 215. When gas
valve 220 is open, gas flows into the bottle through the gas tube set
215, pressurizes the bottle, and passes from the bottle cap 130 to the
endoscope via the annular passage created between the outer surface of
water tube 120 and the inner surface of air tube 110. End 230 of gas tube
set 215 extends through bottle cap 130, to the bottom of the water
bottle. As a result, gas entering the container bubbles up through the
water and is humidified. When the gas is preheated and/or the water is
preheated, the result is a warm, humid gas that is then passed to the
endoscope and then to the patient for insufflation. While end 230 of gas
tube set 215 extends through bottle cap 130 in the embodiment shown, in
other embodiments end 230 may stop at bottle cap 130. In an embodiment
where end 230 of tube set 215 does not extend into the water, the gas
passed to the patient may be pre-humidified or dry gas may be delivered
to the patient.

[0066] In some embodiments, the present application is designed to be used
with warm gas, such as for example, carbon dioxide which is provided to
gas tube set 215 by a carbon dioxide gas source, such as for example a
tank, which is then humidified as it is bubbled through the liquid (e.g.,
water) in the bottle. In some embodiments, the bottle (e.g., 60 in FIG.
2) can be heated by for example an external heating source (e.g., hot
plate, microwave, etc.). In this way the gas and/or liquid in the bottle
can be heated.

[0067] In some embodiments, the gas can be humidified by passing the gas
in the direction of the cap 130 in the opposite direction of water flow
to the fluid in the bottle. In some embodiments, the gas may be
pressurized and fed into the tube under pressure.

[0068] The gas is humidified by bubbling it through the fluid and
pressurizes the bottle, and passes from the bottle cap 130 to the
endoscope via the annular passage created between the outer surface of
water tube 120 and the inner surface of air tube 110. End 230 of gas tube
set 215 extends through bottle cap 130, to the bottom of the water
bottle. In some embodiments, the end of the tube 230 can have a tip
configured to decrease bubble size (e.g., the diameter and/or surface
area of the tip can be reduced) to increase the rate of humidification as
the smaller bubbles will increase the humidification rate of the gas. In
some embodiments, the tip of the gas tube can be angled to increase the
orifice size so that the gas exiting it has decreased surface area. The
gas will pressurize the bottle and the humidified gas will pass through
inner surface of air tube 110 and to adapter 103 next to air/water tube
104 to the endoscope.

[0069] In some embodiments, the air/water tube 104 has outer surface of
water tube 120 running within inner surface of air tube 110 creating an
annular passage between the outer surface of water tube 120 and the inner
surface of air tube 110 to allow air and fluid out of the tube to the
adapter 103 to air/water tube 104 to the endoscope. It will be understood
that the combined air/water tube can be a tube within a tube structure as
shown in FIG. 5B or two separate tubes that do not have a tube within a
tube structure (not shown). In some embodiments, the outer surface of the
water tube 120 runs continuously or discontinuously within the air tube
110. In the embodiment shown in FIG. 5B, the water tube protrudes from
the cap 130 into the bottle, but the air tube does not run into the
bottle. The water tube 120 is discontinuous with the air tube 110. In
some embodiments, the cap 130 may further comprise rims 131 that protrude
from the cap and guide the tubes. It will be understood that the cap 130
can have none, one, two, three, four, five or more rims that guide the
tubes out of the cap. In some embodiments, the cap 130 can have one, two,
three, four, five or more channels that allow the one or more tubes to
pass through them. In FIG. 5B, there are three channels that allow the
tube to pass through it, but there is still an air tight seal so only air
and liquid can pass out of the bottle through the tube assembly. In some
embodiments, and as shown in FIG. 5B, the irrigation tube has flexible
section or portion 107 that is more flexible than the rest of the
irrigation tube 106. The flexible section or portion 107 is configured to
be connected to a pump that allows pumping of the irrigation fluid to the
endoscope which can be connected at connector 226. It will be understood
that in some embodiments, the irrigation tube, air/water tube and/or the
gas tube can have one or more flexible sections, where the tube is more
flexible than other sections. It will also be understood that in some
embodiments, the irrigation tube, air/water tube and/or the gas tube can
have one or more filters, vents, check valves, pinch clips, adapters,
and/or connectors disposed above the bottle cap 130. In some embodiments,
the air/water tube 104 can have a pinch clip disposed above the bottle
cap 130 to stop flow of the gas and/or liquid in the tube. It will be
understood that the adapter or connector can be configured to be a
permanent part of the tubing, and therefore, not removable without
damaging the tubing or it can be configured to be removed from the tubing
without damaging the tubing (e.g., a twist and pull fitting, push
fitting, pull fitting, twist-off fitting, Luer lock, or the like). In
some embodiments, the cap can be vented or not have a vent.

[0070] FIG. 5C illustrates an embodiment of a universal connector or
adapter 250 for a combined irrigation and air/water tube set attached to
an endoscope 72. The air/water tube set 104 and the irrigation tube set
106 bring gas and/or fluid (e.g., water, saline, dextrose, etc.) to the
adapter. Air tube 265 and water tube 260 are shown as separate tubes.
These tubes can also be combined into one as concentric tubes (not
shown). The air tube 265 and water tube 260 run into their respective
ports of the air/water connector 140 and, therefore, air and/or water can
be drawn into the tubes as required by the user of the endoscope.
Irrigation tube 255 can connect to the auxiliary water connector 150,
which will allow irrigation fluid to be drawn to the auxiliary water
connector 150 and then to the endoscope as needed.

[0071] In some embodiments, the adapter can be removably attached to the
plurality of tubes, for example, by a fitting or permanently attached to
the plurality of tubes. In some embodiments, the adapter comprises a
universal adapter that comprises a portion of a plurality of tubes and
connectors that can attach to other adapters, connectors, tubes, and/or
any endoscope. The user connects the tube set having irrigation tube set
106, air/water tube set 104 to the adapter input connector 240 (the lower
portion of these tubes shown below adapter input connector 240). The
adapter input connector 240 can then be attached to air tube 265, water
tube 260 and irrigation tube 255 (the upper portions of these tubes shown
above adapter input connector 240). Each of these tubes have their own
connectors (auxiliary water connector 150) (air/water connector 140)
configured to be attached to endoscope 72. In this way, the adapter 250
can be a universal adapter and have tubing and connectors designed for a
specific endoscope and the user merely connects the adapter to the tube
set (below 240) by connecting the tubes into the adapter input connector
240. Therefore, the tube set can be customized to the specific endoscope
being used. In some embodiments, the adapter allows connection to a
variety of different endoscopes. In some embodiments, the universal
connector is compatible with a tube set, and the tube set is compatible
with a variety of adapters that are compatible with a variety of
endoscopes. In some embodiments, it will be understood that the adapter
240 can be permanently attached to the plurality of tubes and not be
detachable.

[0072] In some embodiments, there is a tube assembly comprising: a first
tube set configured to provide a liquid and a gas to an instrument 72,
the first tube set comprising a first tube 265 configured to provide air
to the instrument and a second tube 260 configured to provide liquid to
the instrument; a second tube set comprising a second tube 255 configured
to provide the liquid to the instrument and a bottle cap contacting at
least the first tube set and the second tube set.

[0073] In some embodiments, there is a tube assembly comprising: a first
tube set configured to provide a liquid and a gas to an instrument 72,
the first tube set comprising a first tube 265 configured to provide air
to the instrument and a second tube 260 configured to provide liquid to
the instrument; a second tube set comprising a second tube 255 configured
to provide a second liquid to the instrument and a bottle cap contacting
at least the first tube set and the second tube set, wherein the second
tube set comprises a flexible section configured to be connected to a
pump; and a third tube set comprising a third tube configured to provide
gas to the instrument. In some embodiments, there will be a first liquid
in one tube and a second liquid in another tube. The first and second
liquid can be the same type of liquid (e.g., water as the first and
second liquid) or the first and second liquid can be a different type of
liquid (e.g., water as the first liquid and saline as the second liquid).
Therefore, in some embodiments, the irrigation fluid and rinsing fluid
can be the same type of fluid (e.g., water, saline, or dextrose, etc.)
from the same bottle. It will be understood that the tube assembly, in
some embodiments, can be used with a single bottle or multiple water
bottles. Alternatively, the bottle can have one, two, three, four or more
compartments that contact the tube set, each compartment can have the
same fluid in it in all the compartments or a different fluid in each
compartment from the single bottle.

[0074] Optionally the first tube runs in an interior of a bottle and at
least the third tube runs in the interior of the bottle, and the first
tube set, second tube set and third tube set run out of a bottle cap,
each of the first tube set, second tube set and third tube set comprise
at least one of an adapter, a connector, a valve, a filter, pinch clip,
or a vent.

[0075] In some embodiments, when gas (e.g., carbon dioxide gas) enters
through the gas input (e.g., third tube set) tube set and the end of the
gas input tube set is extended into the liquid (e.g., water), there is a
risk of liquid intake tubes taking in the gas bubbles instead of liquid.
This may happen if the entrance to a liquid (e.g., water) intake tube is
located next to the gas input tube's outlet or if the entrance to a
liquid intake tube is located above the gas input tube's outlet. In the
latter case, the bubbles may rise to the end of the liquid intake tube.
When a liquid intake tube takes in the gas bubbles, the gas is fed to the
medical instrument (e.g., endoscope) instead of a steady stream of
liquid. The result is a less effective lens rinsing or irrigation effect.

[0076] Therefore, in some embodiments, a gas input tube whose length under
the bottle cap is shorter than the length of one or more of the other
liquid intake tubes is provided. In some embodiments, one or more tubes
in the tube set can be the same or different lengths.

[0077] In some embodiments, in addition to the lengths of the tubes being
the same or different, there is a separating member (e.g., bracket, clip,
hook, loop, prong, channel, spacer, or other separator, or the like) that
contacts one or more tubes and separates the gas input tube from any
liquid intake tube. The separating member may force a horizontal
separation and/or vertical separation between one or more tubes. In some
embodiments, the separating member may force a vertical separation so
that the gas bubbles are introduced to the liquid at a level higher than
that of the liquid intake. In some embodiments, one or more tubes of the
device are preformed into some predetermined shape so that the gas
bubbles are directed away from the liquid intake tubes. In an embodiment
in which the tube sets are constructed from a common, multi-lumen tube,
the gas input lumen can be plugged and a hole in the tube wall would be
cut for the gas to exit the tube at a higher level.

[0078] In some embodiments, the first, second, third and/or fourth tube
can be concentric with each other. Therefore, the present application
contemplates four tubes combined into one, three tubes combined into one,
two tubes combined into one for delivery of liquid and/or gas to a
medical instrument. In some embodiments, the present application
contemplates using single, double, triple and/or quadruple lumen tubes
for delivery of liquid and/or gas to a medical instrument.

[0079] In some embodiments, the cap comprises a liner for an air-tight
seal. In some embodiments, the length of the first, second, and third
tube set is longer in length than the portion of the tube set contained
within the bottle.

[0080] FIG. 6A is an illustrative embodiment of a universal fit bottle cap
300, and FIG. 6B is an isometric view of an illustrative embodiment of a
universal fit bottle cap 300. Bottle cap 300 may optionally utilize a
liner or seal (not shown) to create an air tight seal with a water
bottle. Thread(s) 310 on the inner surface of universal fit bottle cap
300 have specific cross-sectional geometry and thread pitch that allow
the cap to be utilized with a variety of water bottles. The material from
which the cap is made has specific structural and tribological properties
(including Young's modulus and coefficient of friction). The dimensions,
geometry and pitch of the threads, and material properties of universal
fit bottle cap 300 allow it to mate to any of several commercially
available water bottles even though the designs of these water bottles
vary.

[0081] Similarly, the liner material has certain structural and
tribological properties (including durometer and coefficient of
friction). The liner also has a certain cross-sectional profile. The
combined effect of the liner's profile and material properties allow it
to form an air tight seal between the bottle cap and any of several
different water bottles. Specifically, the inner surface of the liner is
shaped so as to continuously contact the bottle around its full
circumference, thus sealing the system. If the system is not sealed, it
will not function properly. Given that different bottles have rims or
ridges of different diameters and at different heights relative to their
threads, the liner has a varying inner diameter designed to accommodate
each bottle design by contacting it at the appropriate height and
diameter. The liner may, if desirable, use gaps along the surface
contacting the cap in order to allow the liner to conform to the bottle
rim. The liner may be formed separately and inserted into the bottle cap.
Alternately, the liner may be formed directly into the bottle cap, such
as by the process of over molding. Alternately, the bottle cap and the
liner may be formed as one contiguous body. Additionally, the liner may
also be used to form an air-tight seal between the bottle cap and the
aforementioned tube sets.

[0082] The bottle cap is preferably made from a rigid polymer such as
acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC),
polystyrene, or polycarbonate. In the embodiment shown, thread 310 has a
pitch of 0.160'', and thread 310 may travel through a certain number of
revolutions. Creating too many revolutions will limit the bottle geometry
with which the bottle cap can mate. However, creating too few revolutions
can prevent the cap from making a reliable connection to the water
bottle. In the embodiment shown, thread 310 travels 1.75 revolutions. The
inner diameter of universal fit bottle cap 300 above and below the
threads 310 should preferably be wide enough to allow the top of the
bottle to pass into region 320 above threads 310. If the inner diameter
of universal fit bottle cap 300 is too narrow, it will not be able to
travel as far onto the bottle as needed in order to engage the liner for
an air-tight seal.

[0083] Thread 310 should have a cross section which is thicker at the base
(where it meets the wall of the bottle cap) and thinner at the inner
surface (nearest the bottle neck). This geometry would resemble a
trapezoid. In the present embodiment, the innermost surface should have a
thickness of about 0.035'' and the thickest portion (near the wall)
should have a thickness of about 0.090''.

[0084] The thread has a minor diameter, measured as the distance across
the thread at its surface that extends farthest from the wall of the
bottle cap. The thread has a major diameter, measured as the distance
across the thread at its base where it joins the wall of the bottle cap.
In one embodiment of the universal fit bottle cap 300, threads 310 have a
minor diameter of about 1.375'' and a major diameter of about 1.490''. In
another embodiment of the universal fit bottle cap 300, threads 310 have
a minor diameter of 1.300'' and a major diameter of about 1.420''.
Surface 330 on which the threads are formed (the inner cylindrical
surface of the bottle cap) is tapered at an angle of about 2 degrees so
that its diameter is slightly larger at the opening of the cap than at
the opposite end of that surface. In order to ensure smooth movement of
universal fit bottle cap 300 as it is threaded onto the bottle, threads
310 may not have blunt edges and corners in some embodiments. The corners
of the trapezoidal geometry at either end of the 0.035'' wide inner
surface may be rounded with a fillet whose radius is about 0.005''. The
two ends of threads 310 may taper in a ramp-like fashion to provide a
smooth transition from the thread's minor diameter to it minor diameter.

[0085] FIG. 6C is an illustrative embodiment of universal fit bottle cap
300 threaded on a bottle. Liner 350 resides in region between threads 310
and top end 340 of universal fit bottle cap 300. Liner 350 engages bottle
360 when universal fit bottle cap 300 is threaded a sufficient distance
on to the neck of a bottle and passes 320. Bottles from different
manufacturers vary significantly in (1) distance from the bottle thread
to the top rim, (2) distance from the bottle thread to the bottle neck's
largest outer diameter; (3) the diameter of the bottle's rim; and (4) the
bottle neck's largest diameter. The liner is designed to mate to one or
both of the largest neck diameter and the top rim for the various bottle
geometries. Thus, the liner has an inner surface with an inner diameter
that varies over its length. The liner's varying inner diameters and
their positions relative to the bottle cap threads cause the liner to
engage the bottle neck or rim sufficiently to form an air-tight seal.

[0086] In order to maintain pressure within the system to deliver gas for
insufflation and water for rinsing the lens, the system must be
reasonably air tight. The seal between the bottle and the bottle cap may
be maintained by a liner which is a flexible member of the bottle cap
assembly. This liner maintains contact with the cap and the bottle by
deforming as it is squeezed between the rigid materials of the cap and
the bottle. Of particular importance is the geometry of the liner
surfaces that are intended to maintain contact with the bottle and cap. A
single liner design will be able to maintain an air-tight seal between
multiple cap designs and multiple bottle designs. However, in some
embodiments, multiple liners may be utilized. In other embodiments, the
cap and liner may be integrated into a one piece member such that the cap
is a flexible member which forms a seal with the bottle, including
bottles of differing geometry.

[0087] The bottle cap and the bottle neck have mating threads. As the cap
is threaded onto the bottle neck, the liner engages the bottle neck or
the bottle throat and forms the seal. Since bottle thread geometries
vary, a cap and liner design may engage sufficiently with a variety of
bottle geometries sufficiently to hold the cap in place, thus compressing
the liner to form a seal with the bottle.

[0088] FIG. 6D is an illustrative embodiment of a bottle cap 300 and liner
350. Another point at which the system must be sealed is between the cap
300 and the tubes 110 connected to the bottle. This also includes the
bond between the cap and any other tubes that pass through it
necessitating a seal to maintain system pressure. In some cases, the tube
may be bonded to the cap with an adhesive bond, a solvent bond, or a
mechanical lock such as a swaged fitting. However, in other embodiments,
the structural connection between the tube and the cap can make use of a
flexible liner so that no adhesive or solvent bond between the tube and
cap is needed. This liner may occupy the space between the cap and the
tube so that the liner is compressed and thus forms an air-tight seal.

[0089] Alternatively, the liner may surround the tube in the region above
or below the bottle cap, forming a seal by constricting the tube. Given
the proper geometry, the liner's seal against the tube's outer surface
may increase its constriction as the pressure within the system
increases, forcing the flexible liner material against the outer wall of
the tube.

[0090] FIG. 7 is an illustrative embodiment of air filter incorporated
into a bottle cap. Air tube 110 stops in filter housing 370. Filter
housing 370 fits into a nipple 390 of the bottle cap. Water tube 120
passes through the filter medium 380. Water tube 120 and filter medium
380 may be in contact to properly seal the air passageway.

[0091] As water is removed from a water bottle, air must be allowed to
flow into the bottle. In some embodiments, air may enter the bottle
through a filter (microbial, HEPA, etc.) so as to maintain the sterility
of the air and water in the bottle. The irrigation system preferably
includes a backflow valve or check valve to ensure that contaminated
fluid from the patient does not enter the irrigation system e.g.,
unidirectional flow from the bottle to the endoscope and not in the
reverse direction. The irrigation tube that feeds water to the endoscope
is typically used on multiple patients in the course of a day, so
contamination from a patient that enters the tubing may be passed to
subsequent patients. Thus, in some embodiments, a check valve is
desirable for maintaining the sterility of the water in the bottle and in
the tube set.

[0092] In certain procedures, such as ERCP (endoscopic retrograde
cholangiopancreatography), extra precaution should be taken to prevent
contamination of the patient's anatomy. In such procedures, it is
especially desirable to have the protection of a backflow valve (410 In
FIG. 8) in the water path and an air filter (500 FIG. 9A) in the air
path. The connector that contains the backflow valve and air filter may
permanently attach to the tubing of the tube set. Such an embodiment
would require a user to replace the entire tube set if the user is
concerned about contaminants from the endoscope reaching the tube set's
connector. In order to reduce waste and cost, another embodiment features
a connector that is removably attached to the tube set. Thus, the portion
of the connector that has contacted the endoscope can be discarded, and
the tubing, which remains sterile, can receive a new connector with
backflow valve and air filter. A backflow valve within the connector can
prevent contamination from reaching the tube set. If the connector is
removed from the tube set and replaced with a new, sterile connector, the
tube set will remain sterile. Thus, when the tube set with the new
connector is attached to the next endoscope, which is used on the next
patient, the next patient is protected from infection. While it is highly
unlikely that the original air/water connector will become contaminated,
the ability to replace the connector improves the health care provider's
ability to protect the patient.

[0093] FIG. 8 is an illustrative embodiment of an air and water connector
400 with a check valve. The connector employs a movable flap 410 in the
water flow path to prevent water from flowing from the endoscope into the
water tube 420. The flap may be formed from a soft, flexible material
such as a thermoplastic elastomer. The flap may be formed from the same
body that forms a seal around the water intake tube of the endoscope
air/water receptacle. When the pressure in the water tube of the tube set
is higher than that in the endoscope's water intake tube (e.g., when the
bottle is pressurized and the endoscope's lens rinsing water valve is
opened), water will flow from the tube set into the endoscope, forcing
the moveable flap open. When there is no pressure differential, the flap
comes to rest, preferably in a position that closes or nearly closes the
flow path. When the pressure in the water tube of the tube set is lower
than that in the endoscope's water intake tube (e.g., when the
endoscope's lens rinsing water valve is opened and the pressure in the
patient's anatomical lumen is higher than the pressure in the bottle),
water movement will force the moveable flap closed. When the moveable
flap closes, it may close against a feature of the sealing body 430. The
moveable flap may also close against the end of the water tube 450 or a
structural member of the connector assembly. The connector also includes
a body that seals around the water inlet tube of the endoscope so that
water does not leak to the outside or to the air flow path. It should be
noted that some endoscope designs accept water through some other means
than a protruding tube (such as a hole to which the connector must mate
by means of a gasket); the valve described here would similarly prevent
retrograde flow in a design compatible with such an endoscope. In some
embodiments, the valve mechanism described here may also be used to
prevent retrograde flow of air (or other gasses) through the tube set and
endoscope. In embodiments that accept air flow from the endoscope to
pressurize the bottle, the valve would only allow air flow from the
endoscope to the bottle and would prevent air flow from the bottle to the
endoscope. In embodiments that accept air from a separate air source, air
would flow from the bottle to the endoscope and the valve would prevent
flow in the opposite direction.

[0094]FIG. 9A is an illustrative embodiment of an inline air filter
assembly 500. From a biological safety perspective, the air that enters
the water bottle may be filtered via porous medium 520. Air that enters
the water bottle without being filtered may carry infectious
microorganisms. The illustrated embodiment is a filter that forms a part
of the connector that joins the air and water tubes to the bottle cap. As
illustrated, the filter is formed as an annular member that surrounds the
water tube and fills the space between the air tube and the water tube.
The filter is composed of some porous medium 520. Depending on the
structural properties of the filter medium, the filter assembly may
include a structural member 510 with surfaces for bonding to the bottle
cap and the water tube. The water tube may pass through the center of the
filter, as illustrated, or it may pass to the side of the filter. All air
passing through the tube is filtered. As illustrated, the filter assembly
is located where the air tube joins the bottle cap. In other embodiments,
the filter assembly 500 may also be located at the end of the air tube
that connects to the air/water connector. In such an embodiment, the
filter may be incorporated as a structural member 510 of the air/water
connector.

[0095]FIG. 9B is an illustrative embodiment of an inline air filter
assembly having a porous medium 520 to filter air with an offset water
tube passage 530. FIG. 9C illustrates an orthogonal view of an embodiment
of an inline air filter assembly 500 with an offset water tube passage
530 configured to receive a water tube. The porous material 520 is
configured to filter the air that is fed into the bottle. The air filter
assembly comprises structural member 510 that surrounds the filter and
allows easy connection to the water tube 530. The porous media can be
made of polyethersulfone, PTFE, a PVC, acrylic copolymer, polysulfone,
polyvinylidene fluoride, cellulose acetate, cellulose nitrate, mixed
esters of cellulose, nylon, polyamide or a combination thereof. The
filter can be microporous, and the mean pore size of the media is from
about 0.2 micron to about 150 microns. In some embodiments, the filter
can have a mean pore size of about 0.22 micron to about 0.8 micron.

[0096] FIG. 10 is an illustrative embodiment of an air and water connector
400 with a check valve having a movable flap 410 and an inline air filter
440. The illustrated embodiment is a filter that forms a part of the
connector that joins the air and water tubes to the bottle cap. The
filter is composed of some porous medium. All gas passing through the
connector is filtered. The air and water connector includes gasket body
430 for ease of connection to the endoscope.

[0097] FIG. 11A illustrates an embodiment of a top view of the liner and
FIG. 11B illustrates a cross sectional view of an embodiment of a liner
having a substantially L-shaped cross section.

[0098] In some embodiments, a cap is provided with a liner inside the cap
which is capable of sealing on multiple surfaces, specifically of a
variety of bottles including bottles used in medical applications such as
endoscopic systems for example. In some embodiments, the cap comprises a
thread on an inner surface of said cap and a liner inside the cap which
is capable of sealing on multiple surfaces, and a top end wherein the top
end comprises at least an opening. The opening can be a hole to fit a
tubing. In some embodiments, the cap and the liner are made of the same
material including a plastic material, an elastomeric material,
thermoplastic elastomeric material, rigid polymer, acrylonitrile
butadiene styrene (ABS), methyl methacrylate acrylonitrile butadiene
styrene, polyvinyl chloride (PVC), polystyrene, polycarbonate,
polypropylene, nylon, silicone, rubber or combination thereof. In some
embodiments, the cap and the liner can be one contiguous body. In some
embodiments, the liner comprises an inner diameter which is not constant
such that it is capable of engaging a variety of bottle necks of varying
heights and diameters. In some embodiments, the inner diameter decreases
axially toward the top end. In some embodiments, the thread has a first
diameter and second diameter, wherein the first diameter is bigger than
the second diameter. In some embodiments, the thread is a positive
thread.

[0099] In some embodiments, a cap is provided comprising a liner capable
of sealing on multiple surfaces wherein the cap further comprises on an
inner surface a thread, wherein the thread is adapted to engage a variety
of bottles. In some embodiments, the thread has a trapezoid geometry
comprising a first base and a second base, wherein the first base is
larger than the second base and wherein the first base is adjacent to the
wall of the cap. In some embodiments, the trapezoidal geometry comprises
rounded corners. In some embodiments, the cap and the liner are made of
the same material including a plastic material, an elastomeric material,
thermoplastic elastomeric material, rigid polymer, acrylonitrile
butadiene styrene (ABS), methyl methacrylate acrylonitrile butadiene
styrene (MABS), polyvinyl chloride (PVC), polystyrene, polycarbonate,
polypropylene, nylon, silicone, rubber or combination thereof. In some
embodiments, the cap and the liner can be one contiguous body. In some
embodiments, the liner comprises a substantially L-shaped cross section
and has varying inner diameters such that it is capable of engaging a
variety of bottle necks of varying heights and diameters. Examples of
bottles include but are not limited to sterile bottles for medical
applications such as sterile water bottles. In some embodiments, the cap
comprises an air filter. In some embodiments, the cap comprises a top end
and a bottom end, wherein the inner surface is tapered at an angle of
about 2 degrees such that the diameter of the bottom end is larger than
the diameter of the top end. In some embodiments, a cap is provided
comprising at least one gasket such that the gasket provides a seal
between the bottle cap and the bottle. In some embodiments, the seal is
air tight or nearly air tight.

[0100] In some embodiments, the cap comprises a thread on an inner
surface, a liner having at least two sealing surfaces at least partially
above the thread, and a top end, wherein said top end comprises at least
three holes. In some embodiments, at least one of the holes fits an
irrigation tubing. In some embodiments, at least one of the holes fits a
water/air tube set. In some embodiments, at least one of the holes fits a
tubing for insufflation. In some embodiments, a cap is provided that is
capable of sealing on multiple surfaces comprising a liner wherein the
liner comprises a substantially L-shaped cross sectional profile and
having at least two diameters.

[0101] In some embodiments, the cap has a thread on an inner surface,
wherein the thread is adapted for engaging a variety of bottles and the
cap has a top end wherein the top end comprises at least one hole to fit
a tubing. In some embodiments, a cap is provided comprising an inner
surface having positive threads, wherein the threads are adapted for
engaging in a variety of sterile water containers; a top end comprising
at least one opening; said opening having a flexible tubing disposed
therein. In some embodiments, a liner is provided that is capable of
sealing on a variety of caps. In some embodiments, the liner comprises a
substantially L-shaped cross-sectional profile comprising various
diameters. The liner can be made of thermoplastic elastomer, an
elastomeric material, polyvinyl chloride, nylon or combinations thereof.

[0102] In some embodiments, a cap is provided comprising a liner capable
of sealing on multiple surfaces, wherein the cap comprises at least one
hole to fit a tubing and wherein liner seals the area between the cap and
the tubing. In some embodiments, a cap is provided for sealing a sterile
water bottle comprising a thread on an inner surface providing at least
720° of thread engagement with said sterile water bottle; and at
least two sealing surfaces above said thread. In some embodiments, a cap
is provided comprising a liner capable of sealing on multiple surfaces; a
thread on an inner surface; a top end; wherein the top end comprises at
least one hole fit for a tubing wherein the liner seals the area between
the cap and the tubing.

[0103]FIG. 12 illustrates a back view of an embodiment of an air and
water connector with a back flow valve. In this embodiment, end of water
tube 560 can align with moveable flap 530 when hinge 540 is foldably
connected to water tube end 570 and moveable flap 530. When the hinge is
folded, the moveable flap is pressed into water tube end 570 which then
aligns with water tube 550. Moveable flap 530 closes over the end of the
water tube to seal the path and prevent water from flowing from the
endoscope's water input port to the water tube end 560. A portion of the
gasket 510 provides a conduit 520 that is configured to mate with the air
port on the endoscope. The gasket 510 can be made from a flexible
material such as a thermoplastic elastomer. The moveable flap 530 and the
hinge 540 are parts of the gasket. In some embodiments, the air and water
connector can be made by overmolding one or more components together.

[0104]FIG. 13 illustrates a front view of an embodiment of an air and
water connector with a back flow valve. In this embodiment, water tube
end 590 can align with moveable flap 630 when hinge 600 is foldably
connected to water tube end 590 and moveable flap 630. When the hinge is
folded, the moveable flap is pressed into water tube end 590 which then
aligns with water tube 580. Moveable flap 630 closes over the end of the
water tube to seal the path and prevent water from flowing from the
endoscope's water input port to the water tube 580. A portion of the
gasket 620 provides a conduit 610 that is configured to mate with the air
port on the endoscope. The gasket 620 can be made from a flexible
material such as a thermoplastic elastomer. The moveable flap 630 and the
hinge 600 are parts of the gasket. In some embodiments, the air and water
connector can be made by overmolding one or more components together.

[0105] It will be apparent to those skilled in the art that various
modifications and variations can be made to various embodiments described
herein without departing from the spirit or scope of the teachings
herein. Thus, it is intended that various embodiments cover other
modifications and variations of various embodiments within the scope of
the present teachings.